Chapter

3 Food
Parts

3-1 CHARACTERISTICS
3-2 SOURCES, SPECIFICATIONS, AND ORIGINAL CONTAINERS AND
RECORDS
3-3 PROTECTION FROM CONTAMINATION AFTER RECEIVING
3-4 DESTRUCTION OF ORGANISMS OF PUBLIC HEALTH CONCERN
3-5 LIMITATION OF GROWTH OF ORGANISMS OF PUBLIC HEALTH
CONCERN
3-6 FOOD IDENTITY, PRESENTATION, AND ON-PREMISES
LABELING
3-7 CONTAMINATED FOOD
3-8 SPECIAL REQUIREMENTS FOR HIGHLY SUSCEPTIBLE
POPULATIONS

3-1 CHARACTERISTICS

Subparts

3-101 Condition

Condition 3-101.11 Safe, Unadulterated, and Honestly Presented.*

FOOD shall be safe, unADULTERATED, and, as specified under

' 3-601.12, honestly presented.

37
 3-2 SOURCES, SPECIFICATIONS, AND ORIGINAL
CONTAINERS AND RECORDS
Subparts

3-201 Sources
3-202 Specifications for Receiving
3-203 Original Containers and Records

Sources 3-201.11 Compliance with Food Law.*

(A) FOOD shall be obtained from sources that comply with LAW.

(B) FOOD prepared in a private home may not be used or offered for
human consumption in a FOOD ESTABLISHMENT.

(C) PACKAGED FOOD shall be labeled as specified in LAW, including

21 CFR 101 FOOD Labeling, 9 CFR 317 Labeling, Marking Devices,
and Containers, and 9 CFR 381 Subpart N Labeling and
Containers, and as specified under §§ 3-202.17 and 3-202.18.

(D) Fish, other than MOLLUSCAN SHELLFISH, that are intended for
consumption in their raw form and allowed as specified in
Subparagraph 3-401.11(C)(1) may be offered for sale or service if
they are obtained from a supplier that freezes the FISH as specified
under § 3-402.11; or frozen on the PREMISES as specified under
§ 3-402.11 and records are retained as specified under § 3-402.12.

(E) WHOLE-MUSCLE, INTACT BEEF steaks that are intended for

consumption in an undercooked form without a CONSUMER advisory
as specified in ¶ 3-401.11(C) shall be:

(1) Obtained from a FOOD PROCESSING PLANT that, upon request

by the purchaser, packages the steaks and labels them, to
indicate that the steaks meet the definition of WHOLE-MUSCLE,
INTACT BEEF, or

(2) Deemed acceptable by the REGULATORY AUTHORITY based on

other evidence, such as written buyer specifications or invoices,
that indicates that the steaks meet the definition of WHOLE-
MUSCLE, INTACT BEEF, and

(3) If individually cut in a FOOD ESTABLISHMENT:

38
 (a) Cut from WHOLE-MUSCLE INTACT BEEF that is labeled by a
FOOD PROCESSING PLANT as specified in Subparagraph (1) or
identified as specified in Subparagraph (2) of this section,

(b) Prepared so they remain intact, and

(c) If PACKAGED for undercooking in a FOOD ESTABLISHMENT,

labeled as specified in Subparagraph (1) or identified as
specified in (2) of this section.

(F) MEAT and POULTRY that is not a READY-TO-EAT FOOD and is in a

PACKAGED form when it is offered for sale or otherwise offered for
consumption, shall be labeled to include safe handling instructions
as specified in LAW, including 9 CFR 317.2(l) and 9 CFR
381.125(b).

(G) Shell EGGS that have not been specifically treated to destroy all
viable Salmonellae shall be labeled to include safe handling
instructions as specified in LAW, including 21 CFR 101.17(h).

3-201.12 Food in a Hermetically Sealed Container.*

FOOD in a HERMETICALLY SEALED CONTAINER shall be obtained from a

FOOD PROCESSING PLANT that is regulated by the FOOD regulatory
agency that has jurisdiction over the plant.

3-201.13 Fluid Milk and Milk Products.*

Fluid milk and milk products shall be obtained from sources that
comply with GRADE A STANDARDS as specified in LAW.

3-201.14 Fish.*

(A) FISH that are received for sale or service shall be:

(1) Commercially and legally caught or harvested; or

(2) APPROVED for sale or service.

(B) MOLLUSCAN SHELLFISH that are recreationally caught may not be

received for sale or service.

39
3-201.15 Molluscan Shellfish.*

(A) MOLLUSCAN SHELLFISH shall be obtained from sources according

to LAW and the requirements specified in the U.S. Department of
Health and Human Services, Public Health Service, Food and Drug
Administration, National Shellfish Sanitation Program Guide for the
Control of Molluscan Shellfish.

(B) MOLLUSCAN SHELLFISH received in interstate commerce shall be

from sources that are listed in the Interstate Certified Shellfish
Shippers List.

3-201.16 Wild Mushrooms.*

(A) Except as specified in ¶ (B) of this section, mushroom species

picked in the wild shall be obtained from sources where each
mushroom is individually inspected and found to be safe by an
APPROVED mushroom identification expert.

(B) This section does not apply to:

(1) Cultivated wild mushroom species that are grown,

harvested, and processed in an operation that is regulated by
the FOOD regulatory agency that has jurisdiction over the
operation; or

(2) Wild mushroom species if they are in PACKAGED form and

are the product of a FOOD PROCESSING PLANT that is regulated by
the FOOD regulatory agency that has jurisdiction over the plant.

3-201.17 Game Animals.*

(A) If GAME ANIMALS are received for sale or service they shall be:

(1) Commercially raised for food and:

(a) Raised slaughtered, and processed under a voluntary

inspection program that is conducted by the agency that has
animal health jurisdiction, or

(b) Under a routine inspection program conducted by a

regulatory agency other than the agency that has animal
health jurisdiction, and
(c) Raised, slaughtered, and processed according to:

40
(i) LAWS governing MEAT and POULTRY as determined by
the agency that has animal health jurisdiction and the
agency that conducts the inspection program, and

41
 (ii) Requirements which are developed by the agency
that has animal health jurisdiction and the agency that
conducts the inspection program with consideration of
factors such as the need for antemortem and
postmortem examination by an APPROVED veterinarian or
veterinarian’s designee;

(2) Under a voluntary inspection program administered by the

USDA for game animals such as exotic animals (reindeer, elk,
deer, antelope, water buffalo, or bison) that are "inspected and
APPROVED" in accordance with 9 CFR 352 Voluntary Exotic
Animal Program or rabbits that are "inspected and certified" in
accordance with 9 CFR 354 Rabbit Inspection Program;

(3) As allowed by LAW, for wild GAME ANIMALS that are live-
caught:

(a) Under a routine inspection program conducted by a

regulatory agency such as the agency that has animal
health jurisdiction, and

(b) Slaughtered and processed according to:

(i) LAWS governing MEAT and POULTRY as determined by

the agency that has animal health jurisdiction and the
agency that conducts the inspection program, and

(ii) Requirements which are developed by the agency

that has animal health jurisdiction and the agency that
conducts the inspection program with consideration of
factors such as the need for antemortem and
postmortem examination by an APPROVED veterinarian or
veterinarian’s designee; or

(4) As ALLOWED by LAW, for field-dressed wild GAME ANIMALS

under a routine inspection program that ensures the animals:

(a) Receive a postmortem examination by an APPROVED

veterinarian or veterinarian's designee, or

(b) Are field-dressed and transported according to

requirements specified by the agency that has animal
health jurisdiction and the agency that conducts the
inspection program, and

42
 (c) Are processed according to LAWS governing MEAT and
POULTRY as determined by the agency that has animal
health jurisdiction and the agency that conducts the
inspection program.

(B) A GAME ANIMAL may not be received for sale or service if it is a

species of wildlife that is listed in 50 CFR 17 Endangered and
Threatened Wildlife and Plants.

Specifications 3-202.11 Temperature.*

for Receiving
(A) Except as specified in & (B) of this section, refrigerated,
POTENTIALLY HAZARDOUS FOOD shall be at a temperature of 5oC (41oF)
or below when received.

(B) If a temperature other than 5°C (41°F) for A POTENTIALLY

HAZARDOUS FOOD is specified in LAW governing its distribution, such as
LAWS governing milk and MOLLUSCAN SHELLFISH, the FOOD may be
received at the specified temperature. .

(C) Raw shell EGGS shall be received in refrigerated equipment that

maintains an ambient air temperature of 7oC (45oF) or less.

(D) POTENTIALLY HAZARDOUS FOOD that is cooked to a temperature and

for a time specified under '' 3-401.11 - 3-401.13 and received hot
shall be at a temperature of 60oC (140oF) or above.
(E) A FOOD that is labeled frozen and shipped frozen by a FOOD
PROCESSING PLANT shall be received frozen.

(F) Upon receipt, POTENTIALLY HAZARDOUS FOOD shall be free of

evidence of previous temperature abuse.

3-202.12 Additives.*

FOOD may not contain unAPPROVED FOOD ADDITIVES or ADDITIVES that

exceed amounts specified in 21 CFR 170-180 relating TO FOOD
ADDITIVES, generally recognized as safe or prior sanctioned
substances that exceed amounts specified in 21 CFR 181-186,
substances that exceed amounts specified in 9 CFR Subpart C
Section 424.21(b) Food ingredients and sources of radiation, or
pesticide residues that exceed provisions specified in 40 CFR 185
Tolerances for Pesticides in Food.

43
3-202.13 Shell Eggs.*

Shell EGGS shall be received clean and sound and may not exceed
the RESTRICTED EGG tolerances for U.S. CONSUMER Grade B as
specified in 7 CFR Part 56 – Voluntary Grading of Shell Eggs and
United States Standards, Grades, and Weight Classes for Shell Eggs,
and 9 CFR Part 590 – Inspection of Eggs and Egg Products.

3-202.14 Eggs and Milk Products, Pasteurized.*

(A) Liquid, frozen, and dry EGGS and EGG products shall be obtained
pasteurized.

(B) Fluid and dry milk and milk products complying with GRADE A
STANDARDS as specified in LAW shall be obtained pasteurized.

(C) Frozen milk products, such as ice cream, shall be obtained

pasteurized as specified in 21 CFR 135 - Frozen Desserts.

(D) Cheese shall be obtained pasteurized unless alternative

procedures to pasteurization are specified in the CFR, such as
21 CFR 133 - Cheeses and Related Cheese Products, for curing
certain cheese varieties.

3-202.15 Package Integrity.*

FOOD packages shall be in good condition and protect the integrity of

the contents so that the FOOD is not exposed to ADULTERATION or
potential contaminants.

3-202.16 Ice.*

Ice for use as a FOOD or a cooling medium shall be made from

DRINKING WATER.

3-202.17 Shucked Shellfish, Packaging and Identification.

(A) Raw SHUCKED SHELLFISH shall be obtained in nonreturnable

packages which bear a legible label that identifies the:

(1) Name, address, and CERTIFICATION NUMBER of the shucker-

packer or repacker of the MOLLUSCAN SHELLFISH; and
44
 (2) The "sell by" date for packages with a capacity of less than
1.87 L (one-half gallon) or the date shucked for packages with a
capacity of 1.87 L (one-half gallon) or more.

(B) A package of raw SHUCKED SHELLFISH that does not bear a label or
which bears a label which does not contain all the information as
specified under & (A) of this section shall be subject to a hold order,
as allowed by LAW, or seizure and destruction in accordance with
21 CFR Subpart D - Specific Administrative Decisions Regarding
Interstate Shipments, Section 1240.60(d).

3-202.18 Shellstock Identification.*

(A) SHELLSTOCK shall be obtained in containers bearing legible source

identification tags or labels that are affixed by the harvester and each
dealer that depurates, ships, or reships the SHELLSTOCK,
as specified in the National Shellfish Sanitation Program Guide for the
Control of Molluscan Shellfish, and that list:

(1) Except as specified under & (C) of this section, on the

harvester's tag or label, the following information in the following
order:

(a) The harvester's identification number that is assigned by

the SHELLFISH CONTROL AUTHORITY,

(b) The date of harvesting,

(c) The most precise identification of the harvest location or

aquaculture site that is practicable based on the system of
harvest area designations that is in use by the SHELLFISH
CONTROL AUTHORITY and including the abbreviation of the name
of the state or country in which the shellfish are harvested,

(d) The type and quantity of shellfish, and

(e) The following statement in bold, capitalized type: "This tag

is required to be attached until container is empty or retagged
and thereafter kept on file for 90 days;" and

(2) Except as specified in & (D) of this section, on each dealer's

tag or label, the following information in the following order:

(a) The dealer's name and address, and the CERTIFICATION

45
 NUMBER assigned by the SHELLFISH CONTROL AUTHORITY,

(b) The original shipper's CERTIFICATION NUMBER including the

abbreviation of the name of the state or country in which the
shellfish are harvested,

(c) The same information as specified for a harvester's tag

under Subparagraphs (A)(1)(b)-(d) of this section, and

(d) The following statement in bold, capitalized type: "This tag

is required to be attached until container is empty and
thereafter kept on file for 90 days.@

(B) A container of SHELLSTOCK that does not bear a tag or label or that
bears a tag or label that does not contain all the information as
specified under & (A) of this section shall be subject to a hold order,
as allowed by LAW, or seizure and destruction in accordance with
21 CFR Subpart D - Specific Administrative Decisions Regarding
Interstate Shipments, Section 1240.60(d).

(C) If a place is provided on the harvester's tag or label for a dealer's

name, address, and CERTIFICATION NUMBER, the dealer's information
shall be listed first.

(D) If the harvester's tag or label is designed to accommodate each

dealer's identification as specified under Subparagraphs (A)(2)(a) and
(b) of this section, individual dealer tags or labels need not be
provided.

3-202.19 Shellstock, Condition.

When received by a FOOD ESTABLISHMENT, SHELLSTOCK shall be

reasonably free of mud, dead shellfish, and shellfish with broken
shells. Dead shellfish or SHELLSTOCK with badly broken shells shall be
discarded.

3-202.110 Juice Treated.

Pre-PACKAGED JUICE shall:

(A) Be obtained from a processor with a HACCP system as

specified in 21 CFR Part 120;

(B) Be obtained pasteurized or otherwise treated to attain a 5-log

46
 reduction of the most resistant microorganism of public health
significance as specified in 21 CFR Part 120.24; or

(C) Bear a warning label as specified in 21 CFR Section

101.17(g).

3-203.11 Molluscan Shellfish, Original Container.

(A) Except as specified in && (B) and (C) of this section, MOLLUSCAN
SHELLFISH may not be removed from the container in which they are
received other than immediately before sale or preparation for
service.

Original (B) For display purposes, SHELLSTOCK may be removed from the
Containers and container in which they are received, displayed on drained ice, or held
Records in a display container, and a quantity specified by a CONSUMER may be
removed from the display or display container and provided to the
CONSUMER if:

(1) The source of the SHELLSTOCK on display is identified as

specified under ' 3-202.18 and recorded as specified under
' 3-203.12; and

(2) The SHELLSTOCK are protected from contamination.

(C) SHUCKED SHELLFISH may be removed from the container in which

they were received and held in a display container from which
individual servings are dispensed upon a CONSUMER'S request if:

(1) The labeling information for the shellfish on display as specified

under ' 3-202.17 is retained and correlated to the date when, or
dates during which, the shellfish are sold or served; and

(2) The shellfish are protected from contamination.

3-203.12 Shellstock, Maintaining Identification.*

(A) Except as specified under Subparagraph (B)(2) of this section,

SHELLSTOCK tags shall remain attached to the container in which the
shellstock are received until the container is empty.

(B) The identity of the source of SHELLSTOCK that are sold or served
shall be maintained by retaining SHELLSTOCK tags or labels for 90
calendar days from the date the container is emptied by:

47
(1) Using an APPROVED record keeping system that keeps the tags
or labels in chronological order correlated to the date when, or
dates during which, the SHELLSTOCK are sold or served; and

(2) If SHELLSTOCK are removed from their tagged or labeled

container:

(a) Preserving source identification by using a record keeping

system as specified under Subparagraph (B)(1) of this section,
and

(b) Ensuring that SHELLSTOCK from one tagged or labeled

container are not COMMINGLED with SHELLSTOCK from another
container before being ordered by the consumer.

48
Clarification of & 3-301.11(B) of the Food Code
with respect to the phrase "Except...when otherwise APPROVED"...

The following information is not part of Chapter 3 and is not intended to be included in the
codified portion of the Food Code. In cases where the Food Code is adopted through
incorporation by reference, this page may be removed.

In response to a 1996 Conference for Food Protection (CFP) Recommendation that

¶ 3-301.11(B) be modified to include the phrase “or when otherwise APPROVED,” the 1997
Code was amended accordingly. A 1998 CFP Recommendation further suggested
clarification of that added language.

This insert page is provided to alert the reader that FDA has issued, with this Code,
clarification of that phrase and its application. Included in Annex 3 is a full discussion of
both the Public Health Reasons associated with § 3-301.11 and Administrative Guidelines
regarding the criteria under which bare hand contact with ready-to-eat food may be
deemed acceptable in meeting the intent of § 3-301.11.

A HACCP-based approach is applied in the clarification in order to establish a system to

control the principal hazard (i.e., fecal-oral transmission of foodborne pathogens) that is
the target of the Code provision.

A second 1998 CFP Recommendation was made to consult the National Advisory
Committee for the Microbiological Criteria for Foods (NACMCF) for its scientific
recommendations surrounding the transmission of pathogens from food workers to
consumers via ready-to-eat foods.

In November, 1999, the National Advisory Committee for Microbiological Criteria for Foods
reported that bare hand contact with ready-to-eat foods can contribute to the transmission
of foodborne illness and they agreed that the transmission could be interrupted. The
NACMCF found that science does not support an absolute ban at this time on bare hand
contact of ready-to-eat food, and it is the Agency’s position that NACMCF’s
recommendation is in harmony with the Food Code.

• The Food Code does not provide a blanket prohibition to “Bare Hand Contact with
Ready-to-Eat Foods.”

• The guidance for “when otherwise approved” is provided in the Annex for situations
where bare hand contact with ready-to-eat foods is deemed necessary by the retail
food establishment (Annex 3, 1999 Food Code, p.266).
 3-3 PROTECTION FROM CONTAMINATION AFTER RECEIVING

Subparts

3-301 Preventing Contamination by Employees

3-302 Preventing Food and Ingredient Contamination
3-303 Preventing Contamination from Ice Used as a
Coolant
3-304 Preventing Contamination from Equipment,
Utensils, and Linens
3-305 Preventing Contamination from the Premises
3-306 Preventing Contamination by Consumers
3-307 Preventing Contamination from Other
Sources

Preventing 3-301.11 Preventing Contamination from Hands.*

Contamination
by Employees (A) FOOD EMPLOYEES shall wash their hands as specified under
' 2-301.12.

(B) Except when washing fruits and vegetables as specified under

' 3-302.15 or when otherwise APPROVED, FOOD EMPLOYEES may not
contact exposed, READY-TO-EAT FOOD with their bare hands and
shall use suitable UTENSILS such as deli tissue, spatulas, tongs,
SINGLE-USE gloves, or dispensing EQUIPMENT.

(C) FOOD EMPLOYEES shall minimize bare hand and arm contact with
exposed FOOD that is not in a READY-TO-EAT form.S

3-301.12 Preventing Contamination When Tasting.*

A FOOD EMPLOYEE may not use a UTENSIL more than once to taste
FOOD that is to be sold or served.

Preventing Food 3-302.11 Packaged and Unpackaged Food - Separation,

and Ingredient Packaging, and Segregation.*
Contamination
(A) FOOD shall be protected from cross contamination by:

48
(1) Separating raw animal FOODS during storage, preparation,
holding, and display from:

(a) Raw READY-TO-EAT FOOD including other raw animal FOOD

such as FISH for sushi or MOLLUSCAN SHELLFISH, or other raw
READY-TO-EAT FOOD such as vegetables, and

(b) Cooked READY-TO-EAT FOOD;

(2) Except when combined as ingredients, separating types of

raw animal FOODS from each other such as beef, FISH, lamb,
pork, and POULTRY during storage, preparation, holding, and
display by:

(a) Using separate EQUIPMENT for each type, or

(b) Arranging each type of FOOD in EQUIPMENT so that cross

contamination of one type with another is prevented, and

(c) Preparing each type of FOOD at different times or in

separate areas;

(3) Cleaning EQUIPMENT and UTENSILS as specified under

& 4-602.11(A) and SANITIZING as specified under ' 4-703.11;

(4) Except as specified in & (B) of this section, storing the FOOD
in packages, covered containers, or wrappings;

(5) Cleaning HERMETICALLY SEALED CONTAINERS of FOOD of visible

soil before opening;

(6) Protecting FOOD containers that are received PACKAGED

together in a case or overwrap from cuts when the case or
overwrap is opened;

(7) Storing damaged, spoiled, or recalled FOOD being held in the

FOOD ESTABLISHMENT as specified under ' 6-404.11; and

(8) Separating fruits and vegetables, before they are washed as

specified under ' 3-302.15 from READY-TO-EAT FOOD.

49
(B) Subparagraph (A)(4) of this section does not apply to:

(1) Whole, uncut, raw fruits and vegetables and nuts in the shell,
that require peeling or hulling before consumption;

(2) PRIMAL CUTS, quarters, or sides of raw MEAT or slab bacon

that are hung on clean, SANITIZED hooks or placed on clean,
SANITIZED racks;

(3) Whole, uncut, processed MEATS such as country hams, and

smoked or cured sausages that are placed on clean, SANITIZED
racks;

(4) FOOD being cooled as specified under Subparagraph

3-501.15(B)(2); or

(5) SHELLSTOCK.

3-302.12 Food Storage Containers, Identified with Common

Name of Food.

Working containers holding FOOD or FOOD ingredients that are

removed from their original packages for use in the FOOD
ESTABLISHMENT, such as cooking oils, flour, herbs, potato flakes,
salt, spices, and sugar shall be identified with the common name of
the FOOD except that containers holding FOOD that can be readily
and unmistakably recognized such as dry pasta need not be
identified.

3-302.13 Pasteurized Eggs, Substitute for Raw Shell Eggs

for Certain Recipes.*

Pasteurized EGGS or EGG products shall be substituted for raw shell

EGGS in the preparation of FOODS such as Caesar salad, hollandaise
or Béarnaise sauce, mayonnaise, eggnog, ice cream, and EGG-
fortified BEVERAGES that are not:

(A) Cooked as specified under Subparagraphs 3-401.11(A)(1) or

(2); or

(B) Included in ¶ 3-401.11(D).

50
 3-302.14 Protection from Unapproved Additives.*

(A) FOOD shall be protected from contamination that may result from
the addition of, as specified in ' 3-202.12:

(1) Unsafe or unAPPROVED FOOD or COLOR ADDITIVES; and

(2) Unsafe or unAPPROVED levels of APPROVED FOOD and COLOR

ADDITIVES.

(B) A FOOD EMPLOYEE may not:

(1) Apply sulfiting agents to fresh fruits and vegetables intended

for raw consumption or to a FOOD considered to be a good
source of vitamin B1; or

(2) Serve or sell FOOD specified under Subparagraph (B)(1) of

this section that is treated with sulfiting agents before receipt by
the FOOD ESTABLISHMENT, except that grapes need not meet this
subparagraph.

3-302.15 Washing Fruits and Vegetables.

(A) Raw fruits and vegetables shall be thoroughly washed in water

to remove soil and other contaminants before being cut, combined
with other ingredients, cooked, served, or offered for human
consumption in READY-TO-EAT form except as specified in & (B) of
this section and except that whole, raw fruits and vegetables that
are intended for washing by the CONSUMER before consumption
need not be washed before they are sold.

(B) Fruits and vegetables may be washed by using chemicals as

specified under ' 7-204.12.

Preventing 3-303.11 Ice Used as Exterior Coolant, Prohibited as

Contamination Ingredient.
from Ice Used
as a Coolant After use as a medium for cooling the exterior surfaces of FOOD
such as melons or FISH, PACKAGED FOODS such as canned
BEVERAGES, or cooling coils and tubes of EQUIPMENT, ice may not be
used as FOOD.

51
 3-303.12 Storage or Display of Food in Contact with Water
or Ice.

(A) PACKAGED FOOD may not be stored in direct contact with ice or
water if the FOOD is subject to the entry of water because of the
nature of its packaging, wrapping, or container or its positioning in
the ice or water.

(B) Except as specified in && (C) and (D) of this section,

unPACKAGED FOOD may not be stored in direct contact with
undrained ice.

(C) Whole, raw fruits or vegetables; cut, raw vegetables such as

celery or carrot sticks or cut potatoes; and tofu may be immersed in
ice or water.

(D) Raw chicken and raw FISH that are received immersed in ice in
shipping containers may remain in that condition while in storage
awaiting preparation, display, service, or sale.

Preventing 3-304.11 Food Contact with Equipment and Utensils.*

Contamination
from Equipment, FOOD shall only contact surfaces of EQUIPMENT and UTENSILS that
Utensils, and are cleaned as specified under Part 4-6 of this Code and SANITIZED
Linens as specified under Part 4-7 of this Code.

3-304.12 In-Use Utensils, Between-Use Storage.

During pauses in FOOD preparation or dispensing, FOOD preparation

and dispensing UTENSILS shall be stored:

(A) Except as specified under & (B) of this section, in the FOOD
with their handles above the top of the FOOD and the container;

(B) In FOOD that is not POTENTIALLY HAZARDOUS with their handles

above the top of the FOOD within containers or EQUIPMENT that
can be closed, such as bins of sugar, flour, or cinnamon;

52
 (C) On a clean portion of the FOOD preparation table or cooking
EQUIPMENT only if the in-use UTENSIL and the FOOD-CONTACT
surface of the FOOD preparation table or cooking EQUIPMENT are
cleaned and SANITIZED at a frequency specified under
'' 4-602.11 and 4-702.11;

(D) In running water of sufficient velocity to flush particulates to

the drain, if used with moist FOOD such as ice cream or mashed
potatoes;

(E) In a clean, protected location if the UTENSILS, such as ice

scoops, are used only with a FOOD that is not POTENTIALLY
HAZARDOUS; or

(F) In a container of water if the water is maintained at a

temperature of at least 60oC (140oF) and the container is
cleaned at a frequency specified under Subparagraph
4-602.11(D)(7).

3-304.13 Linens and Napkins, Use Limitation.

LINENS and napkins may not be used in contact with FOOD unless
they are used to line a container for the service of FOODS and the
LINENS and napkins are replaced each time the container is refilled
for a new CONSUMER.

3-304.14 Wiping Cloths, Use Limitation.

(A) Cloths that are in use for wiping FOOD spills shall be used for no
other purpose.

(B) Cloths used for wiping FOOD spills shall be:

(1) Dry and used for wiping FOOD spills from TABLEWARE and
carry-out containers; or

(2) Wet and cleaned as specified under & 4-802.11(D), stored in

a chemical sanitizer at a concentration specified in ' 4-501.114,
and used for wiping spills from FOOD-CONTACT and nonFOOD-
CONTACT SURFACES of EQUIPMENT.

53
(C) Dry or wet cloths that are used with raw animal FOODS shall be
kept separate from cloths used for other purposes, and wet cloths
used with raw animal FOODS shall be kept in a separate sanitizing
solution.

(D) Wet wiping cloths used with a freshly made sanitizing solution
and dry wiping cloths shall be free of FOOD debris and visible soil.

3-304.15 Gloves, Use Limitation.

(A) If used, SINGLE-USE gloves shall be used for only one task such
as working with READY-TO-EAT FOOD or with raw animal FOOD, used
for no other purpose, and discarded when damaged or soiled, or
when interruptions occur in the operation.

(B) Except as specified in & (C) of this section, slash-resistant

gloves that are used to protect the hands during operations
requiring cutting shall be used in direct contact only with FOOD that
is subsequently cooked as specified under Part 3-4 such as frozen
FOOD or a PRIMAL CUT of MEAT.

(C) Slash-resistant gloves may be used with READY-TO-EAT FOOD

that will not be subsequently cooked if the slash-resistant gloves
have a SMOOTH, durable, and nonabsorbent outer surface; or if the
slash-resistant gloves are covered with a SMOOTH, durable,
nonabsorbent glove, or a SINGLE-USE glove.

(D) Cloth gloves may not be used in direct contact with FOOD
unless the FOOD is subsequently cooked as required under Part 3-4
such as frozen FOOD or a PRIMAL CUT of MEAT.

3-304.16 Using Clean Tableware for Second Portions and

Refills.

(A) Except for refilling a CONSUMER=S drinking cup or container

without contact between the pouring UTENSIL and the lip-contact
area of the drinking cup or container, FOOD EMPLOYEES may not use
TABLEWARE, including SINGLE-SERVICE ARTICLES, soiled by the
CONSUMER, to provide second portions or refills.

54
 (B) Except as specified in & (C) of this section, self-service
CONSUMERS may not be allowed to use soiled TABLEWARE, including
SINGLE-SERVICE ARTICLES, to obtain additional FOOD from the display
and serving EQUIPMENT.

(C) Drinking cups and containers may be reused by self-service

CONSUMERS if refilling is a contamination-free process as specified
under && 4-204.13(A), (B), and (D).

3-304.17 Refilling Returnables.

(A) A take-home FOOD container returned to a FOOD ESTABLISHMENT

may not be refilled at a FOOD ESTABLISHMENT with a POTENTIALLY
HAZARDOUS FOOD.

(B) Except as specified in & (C), a take-home FOOD container

refilled with FOOD that is not POTENTIALLY HAZARDOUS shall be
cleaned as specified under & 4-603.17(B).

(C) Personal take-out BEVERAGE containers, such as thermally

insulated bottles, nonspill coffee cups, and promotional BEVERAGE
glasses, may be refilled by EMPLOYEES or the CONSUMER if refilling is
a contamination-free process as specified under && 4-204.13(A),
(B), and (D).

Preventing 3-305.11 Food Storage.

Contamination
from the (A) Except as specified in && (B) and (C) of this section, FOOD shall
Premises be protected from contamination by storing the FOOD:

(1) In a clean, dry location;

(2) Where it is not exposed to splash, dust, or other

contamination; and

(3) At least 15 cm (6 inches) above the floor.

(B) FOOD in packages and working containers may be stored less

than 15 cm (6 inches) above the floor on case lot handling
EQUIPMENT as specified under ' 4-204.122.

55
(C) Pressurized BEVERAGE containers, cased FOOD in waterproof
containers such as bottles or cans, and milk containers in plastic
crates may be stored on a floor that is clean and not exposed to
floor moisture.

3-305.12 Food Storage, Prohibited Areas.

FOOD may not be stored:

(A) In locker rooms;

(B) In toilet rooms;

(C) In dressing rooms;

(D) In garbage rooms;

(E) In mechanical rooms;

(F) Under sewer lines that are not shielded to intercept potential
drips;

(G) Under leaking water lines, including leaking automatic fire

sprinkler heads, or under lines on which water has condensed;

(H) Under open stairwells; or

(I) Under other sources of contamination.

3-305.13 Vended Potentially Hazardous Food, Original

Container.

POTENTIALLY HAZARDOUS FOOD dispensed through a VENDING

MACHINE shall be in the package in which it was placed at the FOOD
ESTABLISHMENT or FOOD PROCESSING PLANT at which it was prepared.

3-305.14 Food Preparation.

During preparation, unPACKAGED FOOD shall be protected from

environmental sources of contamination.

56
Preventing 3-306.11 Food Display.
Contamination
by Consumers Except for nuts in the shell and whole, raw fruits and vegetables
that are intended for hulling, peeling, or washing by the CONSUMER
before consumption, FOOD on display shall be protected from
contamination by the use of packaging; counter, service line, or
salad bar FOOD guards; display cases; or other effective means.

3-306.12 Condiments, Protection.

(A) Condiments shall be protected from contamination by being kept

in dispensers that are designed to provide protection, protected
FOOD displays provided with the proper UTENSILS, original containers
designed for dispensing, or individual packages or portions.

(B) Condiments at a VENDING MACHINE LOCATION shall be in individual

packages or provided in dispensers that are filled at an APPROVED
location, such as the FOOD ESTABLISHMENT that provides FOOD to the
VENDING MACHINE LOCATION, a FOOD PROCESSING PLANT that is
regulated by the agency that has jurisdiction over the operation, or a
properly equipped facility that is located on the site of the VENDING
MACHINE LOCATION.

3-306.13 Consumer Self-Service Operations.*

(A) Raw, unPACKAGED animal FOOD, such as beef, lamb, pork,

POULTRY, and FISH may not be offered for CONSUMER self-service.
This paragraph does not apply to CONSUMER self-service of READY-
TO-EAT FOODS at buffets or salad bars that serve FOODS such as
sushi or raw shellfish; ready-to-cook individual portions for
immediate cooking and consumption on the PREMISES such as
CONSUMER-cooked MEATS or CONSUMER-selected ingredients for
Mongolian barbecue; or raw, frozen, shell-on shrimp or lobster.

(B) CONSUMER self-service operations for READY-TO-EAT FOODS shall

be provided with suitable UTENSILS or effective dispensing methods
that protect the FOOD from contamination.N

(C) CONSUMER self-service operations such as buffets and salad

bars shall be monitored by FOOD EMPLOYEES trained in safe
operating procedures.N

57
 3-306.14 Returned Food and Reservice of Food.*

(A) Except as specified in & (B) of this section, after being served or
sold and in the possession of a CONSUMER, FOOD that is unused or
returned by the CONSUMER may not be offered as FOOD for human
consumption.

(B) Except as specified under & 3-801.11(C), a container of FOOD

that is not POTENTIALLY HAZARDOUS may be transferred from one
CONSUMER to another if:

(1) The FOOD is dispensed so that it is protected from

contamination and the container is closed between uses, such
as a narrow-neck bottle containing catsup, steak sauce, or wine;
or

(2) The FOOD, such as crackers, salt, or pepper, is in an

unopened original PACKAGE and is maintained in sound
condition.

Preventing 3-307.11 Miscellaneous Sources of Contamination.

Contamination
from Other FOOD shall be protected from contamination that may result from a
Sources factor or source not specified under Subparts 3-301 - 3-306.

58
 3-4 DESTRUCTION OF ORGANISMS OF PUBLIC HEALTH CONCERN

Subparts

3-401 Cooking
3-402 Freezing
3-403 Reheating
3-404 Other Methods

Cooking 3-401.11 Raw Animal Foods.*

(A) Except as specified under ¶ (B) and in ¶¶ (C) and (D) of this
section, raw animal FOODS such as EGGS, FISH, MEAT, POULTRY, and
FOODS containing these raw animal FOODS, shall be cooked to heat
all parts of the FOOD to a temperature and for a time that complies
with one of the following methods based on the FOOD that is being
cooked:

(1) 63oC (145oF) or above for 15 seconds for:

(a) Raw shell EGGS that are broken and prepared in response
to a CONSUMER'S order and for immediate service, and

(b) Except as specified under Subparagraphs (A)(2) and (3)

and ¶ (B) of this section, FISH, MEAT, and pork including GAME
ANIMALS commercially raised for FOOD as specified under
Subparagraph 3-201.17(A)(1) and GAME ANIMALS under a
voluntary inspection program as specified under
Subparagraph 3-201.17(A)(2);

(2) 68oC (155oF) for 15 seconds or the temperature specified in

the following chart that corresponds to the holding time for
ratites and INJECTED MEATS; the following if they are
COMMINUTED: FISH, MEAT, GAME ANIMALS commercially raised for
FOOD as specified under Subparagraph 3-201.17(A)(1), and
GAME ANIMALS under a voluntary inspection program as specified
under Subparagraph 3-201.17(A)(2); and raw EGGS that are not
prepared as specified under Subparagraph (A)(1)(a) of this
section:

Minimum

59
 Temperature Time
o
C (oF)
63 (145) 3 minutes
66 (150) 1 minute
70 (158) < 1 second (instantaneous)

;or

(3) 74oC (165oF) or above for 15 seconds for POULTRY, wild

GAME ANIMALS as specified under Subparagraphs 3-201.17(A)(3)
and (4), stuffed FISH, stuffed MEAT, stuffed pasta, stuffed
POULTRY, stuffed ratites, or stuffing containing FISH, MEAT,
POULTRY, or ratites.

(B) Whole beef roasts, corned beef roasts, pork roasts, and cured
pork roasts such as ham, shall be cooked:

(1) In an oven that is preheated to the temperature specified for

the roast's weight in the following chart and that is held at that
temperature:

Oven Type Oven Temperature Based on Roast Weight

Less than 4.5 kg (10 lbs) 4.5 kg (10 lbs) or More

Still Dry 177oC (350oF) or more 121oC (250oF) or more

Convection 163oC (325oF) or more 121oC (250oF) or more

High Humidity1 121oC (250oF) or less 121oC (250oF) or less

1
Relative humidity greater than 90% for at least 1 hour as measured in the cooking chamber or
exit of the oven; or in a moisture-impermeable bag that provides 100% humidity.

;and

(2) As specified in the following chart, to heat all parts of the

FOOD to a temperature and for the holding time that corresponds
to that temperature:

60
Temperature Time1 in Temperature Time1 in
°C (°F) Minutes °C (°F) Seconds
54.4 (130) 112 63.9 (147) 134
55.0 (131) 89 65.0 (149) 85
56.1 (133) 56 66.1 (151) 54
57.2 (135) 36 67.2 (153) 34
57.8 (136) 28 68.3 (155) 22
58.9 (138) 18 69.4 (157) 14
60.0 (140) 12 70.0 (158) 0
61.1 (142) 8
62.2 (144) 5
62.8 (145) 4
1
Holding time may include postoven heat rise.

(C) A raw or undercooked WHOLE-MUSCLE, INTACT BEEF steak may be

served or offered for sale in a READY-TO-EAT form if:

(1) The FOOD ESTABLISHMENT serves a population that is not a

HIGHLY SUSCEPTIBLE POPULATION,

(2) The steak is labeled to indicate that it meets the definition of

AWHOLE-MUSCLE, INTACT BEEF@ as specified under & 3-201.11(E),
and

(3) The steak is cooked on both the top and bottom to a surface
temperature of 63oC (145oF) or above and a cooked color
change is achieved on all external surfaces.

(D) A raw animal FOOD such as raw EGG, raw FISH, raw-marinated
FISH,raw MOLLUSCAN SHELLFISH, or steak tartare; or a partially
cooked FOOD such as lightly cooked FISH, soft cooked EGGS, or rare
MEAT other than WHOLE-MUSCLE, INTACT BEEF steaks as specified in
& (C) of this section, may be served or offered for sale in a READY-
TO-EAT form if:

(1) The FOOD ESTABLISHMENT serves a population that is not a

HIGHLY SUSCEPTIBLE POPULATION, and

61
 (2) The CONSUMER is informed as specified under ' 3-603.11
that to ensure its safety, the FOOD should be cooked as
specified under & (A) or (B) of this section; or

(3) The REGULATORY AUTHORITY grants a VARIANCE from & (A) or

(B) of this section as specified in ' 8-103.10 based on a HACCP
PLAN that:

(a) Is submitted by the PERMIT HOLDER and APPROVED as

specified under ' 8-103.11,

(b) Documents scientific data or other information

showing that a lesser time and temperature regimen
results in a safe FOOD, and

(c) Verifies that EQUIPMENT and procedures for FOOD

preparation and training of FOOD EMPLOYEES at the FOOD
ESTABLISHMENT meet the conditions of the VARIANCE.

3-401.12 Microwave Cooking.*

Raw animal FOODS cooked in a microwave oven shall be:

(A) Rotated or stirred throughout or midway during cooking to

compensate for uneven distribution of heat;

(B) Covered to retain surface moisture;

(C) Heated to a temperature of at least 74oC (165oF) in all parts

of the food; and

(D) Allowed to stand covered for 2 minutes after cooking to

obtain temperature equilibrium.

3-401.13 Plant Food Cooking for Hot Holding.

Fruits and vegetables that are cooked for hot holding shall be
cooked to a temperature of 60oC (140oF).

62
Freezing 3-402.11 Parasite Destruction.*

(A) Except as specified in ¶ (B) of this section, before service or

sale in READY-TO-EAT form, raw, raw-marinated, partially cooked, or
marinated-partially cooked FISH other than MOLLUSCAN SHELLFISH
shall be:

(1) Frozen and stored at a temperature of -20°C (-4°F) or below

for 168 hours (7 days) in a freezer; or

(2) Frozen at -35°C (-31°F) or below until solid and stored at

-35°C (-31°F) for 15 hours.

(B) If the fish are tuna of the species Thunnus alalunga, Thunnus
albacares (Yellowfin tuna), Thunnus atlanticus, Thunnus maccoyii
(Bluefin tuna, Southern), Thunnus obesus (Bigeye tuna), or
Thunnus thynnus (Bluefin tuna, Northern), the FISH may be served
or sold in a raw, raw-marinated, or partially cooked READY-TO-EAT
form without freezing as specified under & (A) of this section.

3-402.12 Records, Creation and Retention.

(A) Except as specified in ¶ 3-402.11(B) and ¶ (B) of this section, if

raw, raw-marinated, partially cooked, or marinated-partially cooked
FISH are served or sold in READY-TO-EAT form, the PERSON IN CHARGE
shall record the freezing temperature and time to which the FISH are
subjected and shall retain the records of the FOOD ESTABLISHMENT
for 90 calendar days beyond the time of service or sale of the FISH.

(B) If the FISH are frozen by a supplier, a written agreement or

statement from the supplier stipulating that the FISH supplied are
frozen to a temperature and for a time specified under ' 3-402.11
may substitute for the records specified under & (A) of this section.

Reheating 3-403.10 Preparation for Immediate Service.

Cooked and refrigerated FOOD that is prepared for immediate

service in response to an individual CONSUMER order, such as a
roast beef sandwich au jus, may be served at any temperature.

63
 3-403.11 Reheating for Hot Holding.*

(A) Except as specified under && (B) and (C) and in & (E) of this
section, POTENTIALLY HAZARDOUS FOOD that is cooked, cooled, and
reheated for hot holding shall be reheated so that all parts of the
o o
FOOD reach a temperature of at least 74 C (165 F) for 15 seconds.

(B) Except as specified under & (C) of this section, POTENTIALLY

HAZARDOUS FOOD reheated in a microwave oven for hot holding shall
be reheated so that all parts of the FOOD reach a temperature of at
least 74oC (165oF) and the FOOD is rotated or stirred, covered, and
allowed to stand covered for 2 minutes after reheating.

(C) READY-TO-EAT FOOD taken from a commercially processed,

HERMETICALLY SEALED CONTAINER, or from an intact package from a
FOOD PROCESSING PLANT that is inspected by the FOOD REGULATORY
AUTHORITY that has jurisdiction over the plant, shall be heated to a
temperature of at least 60oC (140oF) for hot holding.

(D) Reheating for hot holding shall be done rapidly and the time the
FOOD is between the temperature specified under & 3-501.16(A)(2)
and 74oC (165oF) may not exceed 2 hours.

(E) Remaining unsliced portions of roasts of beef that are cooked as

specified under & 3-401.11(B) may be reheated for hot holding
using the oven parameters and minimum time and temperature
conditions specified under & 3-401.11(B).

Other Methods 3-404.11 Treating Juice.

JUICE PACKAGED in a FOOD ESTABLISHMENT shall be:

(A) Treated under a HACCP PLAN as specified in

¶¶ 8-201.12(B) – (E) to attain a 5-log reduction, which is equal
to a 99.999% reduction, of the most resistant microorganism of
public health significance; or

(B) Labeled, if not treated to yield a 5-log reduction of the most

resistant microorganism of public health significance:

(1) As specified under § 3-602.11, and

64
 (2) As specified in 21 CFR 101.17(g) with the phrase,
"WARNING: This product has not been pasteurized and,
therefore, may contain harmful bacteria that can cause
serious illness in children, the elderly, and persons with
weakened immune systems."

3-5 LIMITATION OF GROWTH OF ORGANISMS OF PUBLIC HEALTH

CONCERN

Subparts

3-501 Temperature and Time Control

3-502 Specialized Processing Methods

Temperature 3-501.11 Frozen Food.

and Time
Control Stored frozen FOODS shall be maintained frozen.

3-501.12 Potentially Hazardous Food, Slacking.

Frozen POTENTIALLY HAZARDOUS FOOD that is slacked to moderate the

temperature shall be held:

(A) Under refrigeration that maintains the FOOD temperature at

5oC (41oF) or less, or at 7oC (45oF) or less as specified under
& 3-501.16(A)(2)(b); or

(B) At any temperature if the FOOD remains frozen.

3-501.13 Thawing.

Except as specified in & (D) of this section, POTENTIALLY HAZARDOUS

FOOD shall be thawed:

(A) Under refrigeration that maintains the FOOD temperature at

5oC (41oF) or less, or at 7oC (45oF) or less as specified under
& 3-501.16(A)(2)(b); or

65
 (B) Completely submerged under running water:

(1) At a water temperature of 21oC (70oF) or below,

(2) With sufficient water velocity to agitate and float off loose
particles in an overflow, and

(3) For a period of time that does not allow thawed portions of
o o o o
READY-TO-EAT FOOD to rise above 5 C (41 F), or 7 C (45 F)
as specified under & 3-501.16(A)(2)(b), or

(4) For a period of time that does not allow thawed portions of
a raw animal FOOD requiring cooking as specified under
& 3-401.11(A) or (B) to be above 5oC (41oF), or 7oC (45oF) as
specified under & 3-501.16(A)(2)(b), for more than 4 hours
including:

(a) The time the FOOD is exposed to the running water and
the time needed for preparation for cooking, or

(b) The time it takes under refrigeration to lower the FOOD

temperature to 5oC (41oF), or 7oC (45oF) as specified
under & 3-501.16(A)(2)(b);

(C) As part of a cooking process if the FOOD that is frozen is:

(1) Cooked as specified under & 3-401.11(A) or (B) or

' 3-401.12, or

(2) Thawed in a microwave oven and immediately transferred

to conventional cooking EQUIPMENT, with no interruption in the
process; or

(D) Using any procedure if a portion of frozen READY-TO-EAT FOOD

is thawed and prepared for immediate service in response to an
individual CONSUMER'S order.

3-501.14 Cooling.*

(A) Cooked POTENTIALLY HAZARDOUS FOOD shall be cooled:

(1) Within 2 hours from 60ºC (140ºF) to 21ºC (70°F); and

66
 (2) Within 6 hours from 60ºC (140ºF) to 5ºC (41°F) or less, or to
7ºC (45°F) or less as specified under ¶ 3-501.16 (A)(2)(b).

(B) POTENTIALLY HAZARDOUS FOOD shall be cooled within 4 hours to

5oC (41oF) or less, or to 7oC (45oF) as specified under
& 3-501.16(A)(2)(b) if prepared from ingredients at ambient
temperature, such as reconstituted FOODS and canned tuna.

(C) Except as specified in & (D) of this section, a POTENTIALLY

HAZARDOUS FOOD received in compliance with LAWS allowing a
temperature above 5oC (41oF) during shipment from the supplier as
specified in & 3-202.11(B), shall be cooled within 4 hours to 5oC
(41oF) or less, or 7oC (45oF) or less as specified under
& 3-501.16(A)(2)(b).

(D) Raw shell EGGS shall be received as specified under

¶ 3-202.11(C) and immediately placed in refrigerated equipment that
maintains an ambient air temperature of 7oC (45oF) or less.

3-501.15 Cooling Methods.

(A) Cooling shall be accomplished in accordance with the time and

temperature criteria specified under ' 3-501.14 by using one or more
of the following methods based on the type of FOOD being cooled:

(1) Placing the FOOD in shallow pans;

(2) Separating the FOOD into smaller or thinner portions;

(3) Using rapid cooling EQUIPMENT;

(4) Stirring the FOOD in a container placed in an ice water bath;

(5) Using containers that facilitate heat transfer;

(6) Adding ice as an ingredient; or

(7) Other effective methods.

(B) When placed in cooling or cold holding EQUIPMENT, FOOD

containers in which FOOD is being cooled shall be:

(1) Arranged in the EQUIPMENT to provide maximum heat transfer

67
 through the container walls; and

(2) Loosely covered, or uncovered if protected from overhead

contamination as specified under Subparagraph 3-305.11(A)(2),
during the cooling period to facilitate heat transfer from the
surface of the FOOD.

3-501.16 Potentially Hazardous Food, Hot and Cold

Holding.*

(A) Except during preparation, cooking, or cooling, or when time is

used as the public health control as specified under ' 3-501.19, and
except as specified in ¶ (B) of this section, POTENTIALLY HAZARDOUS
FOOD shall be maintained:

(1) At 60oC (140oF) or above, except that roasts cooked to a

temperature and for a time specified under & 3-401.11(B) or
reheated as specified in & 3-403.11(E) may be held at a
temperature of 54oC (130oF); or

(2) At a temperature and time specified in the following:

(a) At 5oC (41oF) or less for a maximum of 7 days; or

(b) At 7°C (45°F) or between 5°C (41°F) and 7°C (45°F) for a
maximum of 4 days in existing refrigeration EQUIPMENT that is
not capable of maintaining the FOOD at 5°C (41°F) or less if:

(i) The EQUIPMENT is in place and in use in the FOOD

ESTABLISHMENT, and

(ii) Within 5 years of the REGULATORY AUTHORITY'S adoption

of this Code, the EQUIPMENT is upgraded or replaced to
maintain FOOD at a temperature of 5°C (41°F) or less.

(B) Shell EGGS that have not been treated to destroy all viable
Salmonellae shall be stored in refrigerated EQUIPMENT that
maintains an ambient air temperature of 7°C (45°F) or less.

68
 3-501.17 Ready-to-Eat, Potentially Hazardous Food, Date
Marking.*

on-premises (A) Except as specified in ¶ (D) of this section, refrigerated, READY-

preparation TO-EAT, POTENTIALLY HAZARDOUS FOOD prepared and held in a FOOD
$ prepare and ESTABLISHMENT for more than 24 hours shall be clearly marked to
hold cold indicate the date or day by which the FOOD shall be consumed on
the PREMISES, sold, or discarded, based on the temperature and time
combinations specified in ¶ 3-501.16(A)(2). The day of preparation
shall be counted as Day 1.

commercially (B) Except as specified in ¶¶ (D) and (E) of this section, refrigerated,
processed food READY-TO-EAT, POTENTIALLY HAZARDOUS FOOD prepared and
$ open and hold PACKAGED by a FOOD PROCESSING PLANT shall be clearly marked, at
cold the time the original container is opened in a FOOD ESTABLISHMENT
and if the FOOD is held for more than 24 hours, to indicate the date or
day by which the FOOD shall be consumed on the PREMISES, sold, or
discarded, based on the temperature and time combinations
specified in ¶ 3-501.16(A)(2); and

(1) The day the original container is opened in the FOOD

ESTABLISHMENT shall be counted as Day 1; and

(2) The day or date marked by the FOOD ESTABLISHMENT may not
exceed a manufacturer’s use-by date if the manufacturer
determined the use-by date based on FOOD safety.

(C) A refrigerated, READY-TO-EAT POTENTIALLY HAZARDOUS FOOD that

is frequently rewrapped, such as lunchmeat or a roast, or for which
date marking is impractical, such as soft serve mix or milk in a
dispensing machine, may be marked as specified in ¶ (A) or (B) of
this section, or by an alternative method acceptable to the
REGULATORY AUTHORITY.

(D) Paragraphs (A) and (B) of this section do not apply to individual
meal portions served or rePACKAGED for sale from a bulk container
upon a consumer’s request.

(E) Paragraph (B) of this section does not apply to the following
when the face has been cut, but the remaining portion is whole and
intact:

(1) Fermented sausages produced in a federally inspected FOOD

PROCESSING PLANT that are not labeled “Keep Refrigerated” and
which retain the original CASING on the product;

69
 (2) Shelf stable, dry, fermented sausages; and

(3) Shelf stable salt-cured products such as prosciutto and

Parma (ham) produced in a federally inspected FOOD
PROCESSING PLANT that are not labeled “Keep Refrigerated”.

(F) A refrigerated, READY-TO-EAT, POTENTIALLY HAZARDOUS FOOD

ingredient or a portion of a refrigerated, READY-TO-EAT, POTENTIALLY
HAZARDOUS FOOD that is subsequently combined with additional
ingredients or portions of FOOD shall retain the date marking of the
earliest-prepared or first-prepared ingredient.

3-501.18 Ready-to-Eat, Potentially Hazardous Food,

Disposition.*

(A) A FOOD specified in & 3-501.17(A) or (B) shall be discarded if it:

(1) Exceeds either of the temperature and time combinations

specified in ¶ 3-501.16(A)(2), except time that the product is
frozen;

(2) Is in a container or PACKAGE that does not bear a date or day;

or

(3) Is appropriately marked with a date or day that exceeds a

temperature and time combination as specified in
¶ 3-501.16(A)(2).

(B) Refrigerated, READY-TO-EAT, POTENTIALLY HAZARDOUS FOOD

prepared in a FOOD ESTABLISHMENT and dispensed through a VENDING
MACHINE with an automatic shutoff control shall be
discarded if it exceeds a temperature and time combination as
specified in ¶ 3-501.16(A)(2).

3-501.19 Time as a Public Health Control.*

(A) Except as specified under & (B) of this section, if time only,
rather than time in conjunction with temperature, is used as the
public health control for a working supply of POTENTIALLY HAZARDOUS
FOOD before cooking, or for READY-TO-EAT POTENTIALLY HAZARDOUS
FOOD that is displayed or held for service for immediate
consumption:

70
 (1) The FOOD shall be marked or otherwise identified to indicate
the time that is 4 hours past the point in time when the FOOD is
removed from temperature control,

(2) The FOOD shall be cooked and served, served if READY-TO-

EAT, or discarded, within 4 hours from the point in time when the
FOOD is removed from temperature control,

(3) The FOOD in unmarked containers or packages or marked to

exceed a 4 hour limit shall be discarded, and

(4) Written procedures shall be maintained in the FOOD

ESTABLISHMENT and made available to the REGULATORY AUTHORITY
upon request, that ensure compliance with:

(a) Subparagraphs (A)(1)-(4) of this section, and

(b) ' 3-501.14 for FOOD that is prepared, cooked, and

refrigerated before time is used as a public health control.

(B) In a FOOD ESTABLISHMENT that serves a HIGHLY SUSCEPTIBLE

POPULATION, time only, rather than time in conjunction with
temperature, may not be used as the public health control for raw
EGGS.

Specialized 3-502.11 Variance Requirement.*

Processing
Methods A FOOD ESTABLISHMENT shall obtain a VARIANCE from the REGULATORY
AUTHORITY as specified in ' 8-103.10 and under ' 8-103.11 before:

(A) Smoking FOOD as a method of FOOD preservation rather than

as a method of flavor enhancement;

(B) Curing FOOD;

(C) Using FOOD ADDITIVES or adding components such as

vinegar:

(1) As a method of FOOD preservation rather than as a

method of flavor enhancement, or

71
 (2) To render a FOOD so that it is not POTENTIALLY HAZARDOUS;

(D) Packaging FOOD using a REDUCED OXYGEN PACKAGING method

except as specified under ' 3-502.12 where a barrier to
Clostridium botulinum in addition to refrigeration exists;

(E) Operating a MOLLUSCAN SHELLFISH life-support system display

tank used to store and display shellfish that are offered for
human consumption;

(F) Custom processing animals that are for personal use as FOOD
and not for sale or service in a FOOD ESTABLISHMENT; or

(G) Preparing FOOD by another method that is determined by the

REGULATORY AUTHORITY to require a VARIANCE.

Clostridium 3-502.12 Reduced Oxygen Packaging, Criteria.*

botulinum
Controls (A) Except for a FOOD ESTABLISHMENT that obtains a VARIANCE as
specified under ' 3-502.11, a FOOD ESTABLISHMENT that packages
FOOD using a REDUCED OXYGEN PACKAGING method and Clostridium
botulinum is identified as a microbiological HAZARD in the final
PACKAGED form shall ensure that there are at least two barriers in
place to control the growth and toxin formation of C. botulinum.

(B) A FOOD ESTABLISHMENT that packages FOOD using a REDUCED

OXYGEN PACKAGING method and Clostridium botulinum is identified
as a microbiological HAZARD in the final PACKAGED form shall have a
HACCP PLAN that contains the information specified under
& 8-201.14(D) and that:

(1) Identifies the FOOD to be PACKAGED;

(2) Limits the FOOD PACKAGED to a FOOD that does not support the
growth of Clostridium botulinum because it complies with one
of the following:

(a) Has an aw of 0.91 or less,

(b) Has a pH of 4.6 or less,

(c) Is a MEAT or POULTRY product cured at a FOOD PROCESSING

PLANT regulated by the U.S.D.A. using substances specified

72
 in 9 CFR 318.7 Approval of substances for use in the
preparation of products and 9 CFR 381.147 Restrictions on
the use of substances in poultry products and is received in
an intact package, or

(d) Is a FOOD with a high level of competing organisms such

as raw MEAT or raw POULTRY;

(3) Specifies methods for maintaining FOOD at 5oC (41oF) or

below;

(4) Describes how the packages shall be prominently and

conspicuously labeled on the principal display panel in bold type
on a contrasting background, with instructions to:

(a) Maintain the FOOD at 5oC (41oF) or below, and

(b) For FOOD held at refrigeration temperatures, discard the

FOOD if within 14 calendar days of its packaging it is not
served for on-PREMISES consumption, or consumed if served
or sold for off-PREMISES consumption;

(5) Limits the refrigerated shelf life to no more than 14 calendar

days from packaging to consumption or the original
manufacturer's "sell by" or "use by" date, whichever occurs first;

(6) Includes operational procedures that:

(a) Prohibit contacting FOOD with bare hands,

(b) Identify a designated area and the method by which:

(i) Physical barriers or methods of separation of raw FOODS

and READY-TO-EAT FOODS minimize cross contamination,
and

(ii) Access to the processing EQUIPMENT is limited to

responsible trained personnel familiar with the potential
HAZARDS of the operation, and

(c) Delineate cleaning and SANITIZATION procedures for FOOD-

CONTACT SURFACES; and

73
 (7) Describes the training program that ensures that the
individual responsible for the REDUCED OXYGEN PACKAGING
operation understands the:

(a) Concepts required for a safe operation,

(b) EQUIPMENT and facilities, and

(c) Procedures specified under Subparagraph (B)(6) of this

section and & 8-201.14(D).

(C) Except for FISH that is frozen before, during, and after packaging,
a FOOD ESTABLISHMENT may not package FISH using a REDUCED
OXYGEN PACKAGING method.

3-6 FOOD IDENTITY, PRESENTATION, AND ON-PREMISES LABELING

Subparts

3-601 Accurate Representation

3-602 Labeling
3-603 Consumer Advisory

Accurate 3-601.11 Standards of Identity.

Representation
PACKAGED FOOD shall comply with standard of identity requirements
in 21 CFR 131-169 and 9 CFR 319 Definitions and Standards of
Identity or Composition, and the general requirements in 21 CFR
130 - Food Standards: General and 9 CFR 319 Subpart A -
General.

3-601.12 Honestly Presented.

(A) FOOD shall be offered for human consumption in a way that

does not mislead or misinform the CONSUMER.

(B) FOOD or COLOR ADDITIVES, colored overwraps, or lights may not

be used to misrepresent the true appearance, color, or quality of a
FOOD.

74
Labeling 3-602.11 Food Labels.

(A) FOOD PACKAGED in a FOOD ESTABLISHMENT, shall be labeled as

specified in LAW, including 21 CFR 101 - Food Labeling, and 9 CFR
317 Labeling, Marking Devices, and Containers.

(B) Label information shall include:

(1) The common name of the FOOD, or absent a common name,

an adequately descriptive identity statement;

(2) If made from two or more ingredients, a list of ingredients in

descending order of predominance by weight, including a
declaration of artificial color or flavor and chemical
preservatives, if contained in the FOOD;

(3) An accurate declaration of the quantity of contents;

(4) The name and place of business of the manufacturer,

packer, or distributor; and

(5) Except as exempted in the Federal Food, Drug, and

Cosmetic Act ' 403(Q)(3)-(5), nutrition labeling as specified in
21 CFR 101 - FOOD Labeling and 9 CFR 317 Subpart B Nutrition
Labeling.

(6) For any salmonid FISH containing canthaxanthin as a COLOR

ADDITIVE, the labeling of the bulk FISH container, including a list
of ingredients, displayed on the retail container or by other
written means, such as a counter card, that discloses the use of
canthaxanthin.

(C) Bulk FOOD that is available for CONSUMER self-dispensing shall

be prominently labeled with the following information in plain view of
the CONSUMER:

(1) The manufacturer's or processor's label that was provided

with the FOOD; or

(2) A card, sign, or other method of notification that includes the

information specified under Subparagraphs (B)(1), (2), and (5)
of this section.

75
(D) Bulk, unPACKAGED FOODS such as bakery products and
unPACKAGED FOODS that are portioned to CONSUMER specification
need not be labeled if:

(1) A health, nutrient content, or other claim is not made;

(2) There are no state or local LAWS requiring labeling; and

(3) The FOOD is manufactured or prepared on the PREMISES of

the FOOD ESTABLISHMENT or at another FOOD ESTABLISHMENT or a
FOOD PROCESSING PLANT that is owned by the same PERSON and
is regulated by the FOOD regulatory agency that has jurisdiction.

3-602.12 Other Forms of Information.

(A) If required by LAW, CONSUMER warnings shall be provided.

(B) FOOD ESTABLISHMENT or manufacturers' dating information on

FOODS may not be concealed or altered.

76
This page is intended to be blank.
Current Status of Consumer Advisory Language
Regarding ' 3-603.11
The following information is not part of Chapter 3 and is not intended to be included in the
codified portion of the Food Code. It is inserted here to provide a summary of recent events
surrounding the matter of a consumer advisory, addressed in ' 3-603.11 of the Code. In cases
where the Food Code is adopted through incorporation by reference, this page may be removed.

A consensus as to what constitutes satisfactory compliance with ' 3-603.11 was reached at the
1998 Conference for Food Protection (CFP) meeting. A third option for the consumer Areminder@
was added later. This insert page is to alert the reader to the options available to food
establishments in advising consumers of the increased possibility of foodborne illness when
animal-derived foods are eaten raw or undercooked.

Included in Annex 3 is a full discussion of the evolution of the 1998 CFP consensus, satisfactory
compliance, applicability of the Code provision, and the meaning and application of the phrase that
appears in ' 3-603.11, i.e., Aor otherwise processed to eliminate pathogens.@

There are two components to satisfactory compliance: Disclosure and Reminder.

Disclosure is satisfied when:

(1) Items are described, such as:

(a) Oysters on the half-shell (raw oysters),
(b) Raw-EGG Caesar salad, and
(c) Hamburgers (can be cooked to order); or

(2) Items are asterisked to a footnote that states that the items:
(a) Are served raw or undercooked, or
(b) Contain (or may contain) raw or undercooked ingredients.

Reminder is satisfied when the items requiring disclosure are asterisked to a footnote that states:

(1) Regarding the safety of these items, written information is available upon request;1

(2) Consuming raw or undercooked meats, poultry, seafood, shellfish, or EGGS may
increase your RISK of foodborne illness; or

(3) Consuming raw or undercooked meats, poultry, seafood, shellfish, or EGGS may
increase your RISK of foodborne illness, especially if you have certain medical
conditions.
_______________________________
1
Essential criteria for such written information are available, with a downloadable model brochure,
on the CFSAN Web Page at http://www.cfsan.fda.gov. All brochures must meet these essential
criteria.
Consumer 3-603.11 Consumption of Animal Foods that are Raw,
Advisory Undercooked, or Not Otherwise Processed to
Eliminate Pathogens.*

Except as specified in & 3-401.11(C) and Subparagraph

3-401.11(D)(3) and under & 3-801.11(D), if an animal FOOD such as
beef, EGGS, FISH, lamb, milk, pork, POULTRY, or shellfish that is raw,
undercooked, or not otherwise processed to eliminate pathogens is
offered in a READY-TO-EAT form as a deli, menu, vended, or other
item; or as a raw ingredient in another READY-TO-EAT FOOD, the
PERMIT HOLDER shall inform CONSUMERS by brochures, deli case or
menu advisories, label statements, table tents, placards, or other
effective written means of the significantly increased RISK
associated with certain especially vulnerable CONSUMERS eating
such FOODS in raw or undercooked form.

3-7 CONTAMINATED FOOD

Subpart

3-701 Disposition

Disposition 3-701.11 Discarding or Reconditioning Unsafe,

Adulterated, or Contaminated Food.*

(A) A FOOD that is unsafe, ADULTERATED, or not honestly presented

as specified under ' 3-101.11 shall be reconditioned according to
an APPROVED procedure or discarded.

(B) FOOD that is not from an APPROVED source as specified under

'' 3-201.11 through .17 shall be discarded.

(C) READY-TO-EAT FOOD that may have been contaminated by an

EMPLOYEE who has been RESTRICTED or EXCLUDED as specified
under ' 2-201.12 shall be discarded.

(D) FOOD that is contaminated by FOOD EMPLOYEES, CONSUMERS, or

other PERSONS through contact with their hands, bodily discharges,
such as nasal or oral discharges, or other means shall be
discarded.

77
 3-8 SPECIAL REQUIREMENTS FOR HIGHLY SUSCEPTIBLE
POPULATIONS

Subpart

3-801 Additional Safeguards

Additional 3-801.11 Pasteurized Foods, Prohibited Reservice, and

Safeguards Prohibited Food.*

In a FOOD ESTABLISHMENT that serves a HIGHLY SUSCEPTIBLE

POPULATION:

(A) The following criteria apply to JUICE:

(1) For the purposes of this paragraph only, children who are
age 9 or less and receive FOOD in a school, day care setting,
or similar facility that provides custodial care are included as
HIGHLY SUSCEPTIBLE POPULATIONS;

(2) PrePACKAGED JUICE or a prePACKAGED BEVERAGE

containing JUICE, that bears a warning label as specified in 21
CFR, Section 101.17(g) Food Labeling, or a PACKAGED JUICE
or BEVERAGE containing JUICE, that bears a warning label as
specified under ¶ 3-404.11(B) may not be served or offered
for sale; and

(3) UnPACKAGED JUICE that is prepared on the premises for

service or sale in a READY-TO-EAT form shall be processed
under a HACCP PLAN that contains the information specified
under ¶¶ 8-201.14(B) – (E) and as specified in 21 CFR Part
120 – Hazard Analysis and Critical Control Point (HACCP)
Systems, Subpart B Pathogen Reduction, 120.24 Process
controls.

(B) Pasteurized shell EGGS or pasteurized liquid, frozen, or dry

EGGS or EGG products shall be substituted for raw shell EGGS in
the preparation of:

(1) FOODS such as Caesar salad, hollandaise or Béarnaise

sauce, mayonnaise, eggnog, ice cream, and EGG-fortified
BEVERAGES, and

78
 (2) Except as specified in & (E) of this section, recipes in
which more than one EGG is broken and the EGGS are
combined;

(C) FOOD in an unopened original package may not be

re-served; and

(D) The following FOODS may not be served or offered for sale in
a READY-TO-EAT form:

(1) Raw animal FOODS such as raw FISH, raw-marinated

FISH, raw MOLLUSCAN SHELLFISH, and steak tartare,

(2) A partially cooked animal FOOD such as lightly cooked

FISH, rare MEAT, soft-cooked EGGS that are made from
raw shell EGGS, and meringue, and

(3) Raw seed sprouts.

(E) Subparagraph (B)(2) of this section does not apply if:

(1) The raw EGGS are combined immediately before

cooking for one CONSUMER=S serving at a single meal,
cooked as specified under Subparagraph 3-401.11(A)(1),
and served immediately, such as an omelet, soufflé, or
scrambled EGGS;

(2) The raw EGGS are combined as an ingredient

immediately before baking and the EGGS are thoroughly
cooked to a READY-TO-EAT form, such as a cake, muffin,
or bread; or

(3) The preparation of the food is conducted under a

HACCP PLAN that:

(a) Identifies the FOOD to be prepared,

(b) Prohibits contacting READY-TO-EAT FOOD with bare

hands,

(c) Includes specifications and practices that ensure:

79
 (i) Salmonella Enteritidis growth is controlled before
and after cooking, and

(ii) Salmonella Enteritidis is destroyed by cooking the

EGGS according to the temperature and time specified
in Subparagraph 3-401.11(A)(2),

(d) Contains the information specified under

& 8-201.14(D) including procedures that:

(i) Control cross contamination of READY-TO-

EAT FOOD with raw EGGS, and

(ii) Delineate cleaning and SANITIZATION

procedures for FOOD-CONTACT SURFACES, and

(e) Describes the training program that ensures that the

FOOD EMPLOYEE responsible for the preparation of the
FOOD understands the procedures to be used.

80